- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... by staying **True to Life.** **Job Description** The Manager, Senior Global MDR Submission is responsible for... Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment and… more
- Medtronic (Minneapolis, MN)
- Position Description: Sr . Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing ... anywhere in the United States. #LI-DNI. Basic Qualifications: Master's degree in Regulatory Affairs , Biomedical Engineering, Chemistry, or closely related field… more
- Philips (San Diego, CA)
- …Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with ... Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists… more
- Philips (San Diego, CA)
- ** Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and...and product registrations, clinical evaluations in accordance with EU MDR , ISO 13485 and ISO 14155, China NMPA, Canadian… more
- Bausch Health (Bothell, WA)
- …proven and effective aesthetic care options to consumers and physicians alike. Reporting to the Sr Dir, Global Regulatory Affairs , the Sr Manager, ... globally distributed products. This role is not a regional regulatory but global regulatory position which under...Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above). *… more
- J&J Family of Companies (Irvine, CA)
- Senior Regulatory Affairs Program Lead...etc. is required. * Knowledge of the European MDD, MDR and CE marking is preferred. * Familiarity with Risk ... the Medical Tech sector within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Program Lead for International Registration, as part of the… more
- Kelly Services (Cuyahoga Falls, OH)
- Kelly Science & Clinical is seeking a ** Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH.** **Direct Hire** **Shift:** Monday - Friday 8am-5pm ... technology field + 5+ years of progressive experience in regulatory affairs required + Appropriate combination of...be acceptable + Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements required + Experience with medical device… more
- ConvaTec (Lexington, MA)
- …about Convatec, please visit http://www.convatecgroup.com **Job Summary:** In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be ... division's global regulatory strategies and processes. The Senior Regulatory Affairs Specialist will...820 and EU Medical Devices Directive 93/42/EEC / EU MDR 2017/745: + 510(k) submissions, 3-5 minimum + Preparation… more
- AbbVie (Lake Bluff, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - Combination Products and ... with Global industry trends and best practices in combination product and device regulatory affairs , review and comment on changing regulation and guidance. +… more
- Actalent (Cuyahoga Falls, OH)
- …Management System. SKILLS& QUALIFICATIONS REQUIRED + 3-5 years of progressive experience in regulatory affairs required + Prior knowledge of 21CFR 820, ISO13485, ... JOB DESCRIPTION + Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical... MDR QMS requirements required PREFERRED + Bachelor's degree in… more
- Medtronic (Santa Rosa, CA)
- …Rosa, CA or Mounds View, MN. Careers that Change Lives Reporting to the Senior Manager, the Principal Regulatory Affairs Specialist will support Research ... Principal Regulatory Affairs Specialist - Structural Heart...PMAs, IDE and PMA Supplements/Reports, Shonin applications, and EU MDR Technical Documentation in addition to Change Management assessments.… more
- Bausch Health (Bothell, WA)
- …in a science related field. + Should have over 7 years of experience as Sr . Regulatory Affairs Specialist. + Should have experience of independently ... care options to consumers and physicians alike. The Manager, Regulatory Affairs provides direct support to Solta...Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above). +… more
- Healgen Scientific Limited (Houston, TX)
- Regulatory Affairs Specialist Regulatory ...21 CFR Part 820), ISO 13485, and other global regulatory requirements (such as MDR in the EU). ... flow cytometry. About the role The purpose of a Regulatory Affairs Specialist is to ensure compliance...execution. Complete other projects and responsibilities as assigned. The Senior Level RA Specialist will perform the above duties… more
- Abbott (St. Paul, MN)
- …software, vessel closure devices and peripheral stents. **The Opportunity** This **Associate Director Regulatory Affairs ** will work on-site at our St. Paul, MN ... As a manager, the function of an Associate Director Regulatory Affairs is to combine knowledge of...internal stakeholders. + Consults with and provides advice to senior management of the Company on strategies and plans… more
- Abbott (Westford, MA)
- …in engineering, safety management quality, environmental science, scientific discipline or regulatory affairs + Technical experience in chemical, mechanical or ... their health and get on with their lives. **WHAT YOU'LL DO** The Senior Product Stewardship Engineer will support the Vascular Division. This position will lead… more
- Terumo Medical Corporation (Elkton, MD)
- Sr . Quality Compliance Engineer Date: Apr 16, 2024 Req ID: 3191 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Systems & Compliance ... **Job Summary** The Senior Quality Compliance Engineer will work with the ...+ Coordinate input from various stakeholders, such as Medical Affairs and PMS, required to draft Health Hazards Evaluations… more
- AbbVie (North Chicago, IL)
- …in function or related fields, such as Quality Assurance/ Regulatory Affairs , pharmaceutical/device/healthcare industry, compliance/auditing experience ... related industries. + Thorough understanding of international medical device regulatory standards (eg MDR , IVDR, ISO, FDA, etc.). Understanding of GxP (GMP, GLP,… more
- Zimmer Biomet (Warsaw, IN)
- …of the product development process in compliance with Zimmer Biomet procedures and global regulatory requirements + Supports Regulatory Affairs team with the ... documentation, preparation of materials for and conducting pre-submission question regulatory meetings + Supports clinical affairs in...in new product development + FDA QSR and EU MDR medical device regulatory requirements, and industry/… more
- embecta (Andover, MA)
- …collaboration with peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs , Operations, Medical Affairs and Regulatory functions as ... social channels on LinkedIn , Facebook , Instagram and Twitter . The Senior Manager, Systems Engineering will provide leadership to System Engineering discipline in… more
- embecta (Andover, MA)
- …collaboration with peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs , Operations, Medical Affairs and Regulatory functions as ... channels on LinkedIn , Facebook , Instagram and Twitter . **_The Senior Manager, Systems Engineering will provide leadership to System Engineering discipline in… more